BBS-Bioactive Bone Substitutes Plc – Inside information – Positive decision received on the product classification, schedule for the quality system approval to be updated

BBS-Bioactive Bone Substitutes Plc, Company announcement, Insider information, 26 May 2023 at 5:30 p.m. EEST

BBS-Bioactive Bone Substitutes Plc – Inside information – Positive decision received on the product classification, schedule for the quality system approval to be updated

BBS-Bioactive Bone Substitutes Plc has received information today that the Notified Body has approved ARTEBONE® Paste’s product classification as a medical device. The product classification decision is a part of the product approval process. It is particularly significant for the company, as the decision ensures that the CE marking process for the company's first product may proceed in accordance with the targeted simpler and more cost-effective administrative process.

BBS previously (27 March 2023) communicated about certain additional measures that were required by the Notified Body regarding the quality system approval, which the company committed to complete by 1 September. The company has now received additional information about this process, and based on that, the company will likely need additional time to complete the measures. BBS will provide an updated schedule for the approval of the quality system at a later time, but it is the management’s current expectation that this delay in itself should not affect the overall CE marking schedule.

As the company has previously announced, the CE marking process includes two main streams: approval of the quality system and product approval. Obtaining product approval requires cooperation between the Notified Body and the Medicines Agency handling the matter. The Notified Body continues the process regarding both approvals.

Previous disclosures related to the CE marking application:

• 27 March 2023 – BBS-Bioactive Bone Substitutes – Inside information: The final report of the second audit received from the Notified Body, CE marking process may continue and CE marking approval continues to be expected during 2023
• 30 December 2022 – BBS-Bioactive Bone Substitutes Plc - Insider information: BBS updates estimate of the CE marking approval schedule of ARTEBONE® Paste
• 18 November 2022 – BBS-Bioactive Bone Substitutes – Inside information: The first audit completed by the Notified Body, CE marking process may continue as planned
• 9 March 2022 – BBS Bioactive Bone Substitutes Plc has filed the CE-marking application of Artebone® bone void filler to the authorities

For more information, please contact:

Ilkka Kangasniemi, CEO,
+358 40 7080307,
ilkka.kangasniemi@bbs-artebone.fi

Certified Advisor:
Nordic Certified Adviser AB,
+46 70 551 67 29,
info@certifiedadviser.se

BBS in brief

BBS -Bioactive Bone Substitutes Plc is a orthobiology company that started its operations in 2003. We have developed a new product for the treatment of complex bone fractures and bone healing issues. Our goal is to provide next-generation medical products for the treatment of bone injuries in orthopedic surgery. In the pharmaceutical industry, the development and research work require perseverance and courage to innovate. We have a track record of over 20 years in this field. Our company is characterized by expertise, innovation, and dedicated employees who are passionate about their work. Our developed product, ARTEBONE®, is in the final stages of product development, and we are seeking the CE marking to enable its commercialization in the EU market. We are based in Oulu with a medical manufacturing facility in Reisjärvi, holding a manufacturing license. The company's headquarters are in Oulu, and we employ 20 people.

BBS has been listed on Nasdaq First North Growth Market Finland since February 2018.

More information: www.bbs-artebone.fi

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